{
    "info": {
        "nct_id": "NCT05553782",
        "official_title": "Therapeutic Drug Screening Using a Novel Implantable Microdevice (IMD) in Adenoid Cystic Carcinoma (ACC) and Salivary Cancers: a Window of Opportunity Study",
        "inclusion_criteria": "* Participants must have histologically confirmed adenoid cystic carcinoma (ACC) of the salivary glands of the head and neck without evidence of recurrent, metastatic or advanced, incurable disease undergoing definitive surgical management; any stage disease is permitted (American Joint Committee on Cancer 2017 8th edition). If initial fine needle aspiration (FNA) biopsy shows findings suggestive of ACC or a basaloid neoplasm, the patient is considered eligible. Initial FNAs showing unspecified salivary neoplasms should be discussed with the treating surgeon and PI.\n* Age 18 years or older.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* A measurable primary tumor site both clinically and radiologically measuring at least 1 x 1 cm.\n* Patients must be deemed medically fit to undergo both percutaneous and surgical procedures by their treating head and neck surgeon and medical oncologist.\n* Participants will undergo laboratory testing within 7 days prior to the microdevice placement: they are required to have a platelet count ≥50,000/mcL, PT/INR <2, and aPTT <1.5x upper limit of normal.\n* Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 14 days\n* Ability to understand and the willingness to sign a written informed consent document.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Participants who are receiving any other investigational agents.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit the safety of a biopsy and/or surgery.\n* Pregnant women are excluded from this study because of the possible increased dose of radiation from imaging associated with the device placement and the potential risk to the pregnancy of the surgery/device placement.\n* Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or percutaneous biopsy procedures. If the patient is on systemic anticoagulation, this should be discussed with the overall PI and treating surgeon",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Participants must have histologically confirmed adenoid cystic carcinoma (ACC) of the salivary glands of the head and neck without evidence of recurrent, metastatic or advanced, incurable disease undergoing definitive surgical management; any stage disease is permitted (American Joint Committee on Cancer 2017 8th edition). If initial fine needle aspiration (FNA) biopsy shows findings suggestive of ACC or a basaloid neoplasm, the patient is considered eligible. Initial FNAs showing unspecified salivary neoplasms should be discussed with the treating surgeon and PI.",
            "criterions": [
                {
                    "exact_snippets": "histologically confirmed adenoid cystic carcinoma (ACC) of the salivary glands of the head and neck",
                    "criterion": "adenoid cystic carcinoma (ACC)",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        },
                        {
                            "requirement_type": "location",
                            "expected_value": "salivary glands of the head and neck"
                        }
                    ]
                },
                {
                    "exact_snippets": "without evidence of recurrent, metastatic or advanced, incurable disease",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": [
                                "no recurrent",
                                "no metastatic",
                                "no advanced",
                                "no incurable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "undergoing definitive surgical management",
                    "criterion": "surgical management",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "undergoing definitive"
                        }
                    ]
                },
                {
                    "exact_snippets": "any stage disease is permitted (American Joint Committee on Cancer 2017 8th edition)",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "any stage"
                        }
                    ]
                },
                {
                    "exact_snippets": "If initial fine needle aspiration (FNA) biopsy shows findings suggestive of ACC or a basaloid neoplasm, the patient is considered eligible",
                    "criterion": "fine needle aspiration (FNA) biopsy findings",
                    "requirements": [
                        {
                            "requirement_type": "suggestive findings",
                            "expected_value": [
                                "ACC",
                                "basaloid neoplasm"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Initial FNAs showing unspecified salivary neoplasms should be discussed with the treating surgeon and PI",
                    "criterion": "unspecified salivary neoplasms",
                    "requirements": [
                        {
                            "requirement_type": "discussion",
                            "expected_value": "with treating surgeon and PI"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age 18 years or older.",
            "criterions": [
                {
                    "exact_snippets": "Age 18 years or older.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A measurable primary tumor site both clinically and radiologically measuring at least 1 x 1 cm.",
            "criterions": [
                {
                    "exact_snippets": "A measurable primary tumor site both clinically and radiologically",
                    "criterion": "primary tumor site",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "measuring at least 1 x 1 cm",
                    "criterion": "primary tumor site size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "cm"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be deemed medically fit to undergo both percutaneous and surgical procedures by their treating head and neck surgeon and medical oncologist.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be deemed medically fit",
                    "criterion": "medical fitness",
                    "requirements": [
                        {
                            "requirement_type": "assessment",
                            "expected_value": "fit"
                        }
                    ]
                },
                {
                    "exact_snippets": "to undergo both percutaneous and surgical procedures",
                    "criterion": "ability to undergo procedures",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "percutaneous",
                                "surgical"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "by their treating head and neck surgeon and medical oncologist",
                    "criterion": "approval by medical professionals",
                    "requirements": [
                        {
                            "requirement_type": "professionals",
                            "expected_value": [
                                "head and neck surgeon",
                                "medical oncologist"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants will undergo laboratory testing within 7 days prior to the microdevice placement: they are required to have a platelet count ≥50,000/mcL, PT/INR <2, and aPTT <1.5x upper limit of normal.",
            "criterions": [
                {
                    "exact_snippets": "platelet count ≥50,000/mcL",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50000,
                                "unit": "mcL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PT/INR <2",
                    "criterion": "PT/INR",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aPTT <1.5x upper limit of normal",
                    "criterion": "aPTT",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "x upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 14 days",
            "criterions": [
                {
                    "exact_snippets": "Female subjects of childbearing potential",
                    "criterion": "female subjects of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "negative urine or serum pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 14 days",
                    "criterion": "pregnancy test timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ability to understand and the willingness to sign a written informed consent document.",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign a written informed consent document",
                    "criterion": "willingness to consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Participants who are receiving any other investigational agents.",
            "criterions": [
                {
                    "exact_snippets": "Participants who are receiving any other investigational agents",
                    "criterion": "receiving investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit the safety of a biopsy and/or surgery.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection",
                    "criterion": "ongoing or active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ... symptomatic congestive heart failure",
                    "criterion": "symptomatic congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ... unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ... cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ... psychiatric illness/social situations that would limit the safety of a biopsy and/or surgery",
                    "criterion": "psychiatric illness/social situations",
                    "requirements": [
                        {
                            "requirement_type": "impact on safety of biopsy and/or surgery",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant women are excluded from this study because of the possible increased dose of radiation from imaging associated with the device placement and the potential risk to the pregnancy of the surgery/device placement.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant women are excluded",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or percutaneous biopsy procedures. If the patient is on systemic anticoagulation, this should be discussed with the overall PI and treating surgeon",
            "criterions": [
                {
                    "exact_snippets": "Uncorrectable bleeding or coagulation disorder",
                    "criterion": "bleeding or coagulation disorder",
                    "requirements": [
                        {
                            "requirement_type": "correctability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "known to cause increased risk with surgical or percutaneous biopsy procedures",
                    "criterion": "risk with surgical or percutaneous biopsy procedures",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": "increased"
                        }
                    ]
                },
                {
                    "exact_snippets": "patient is on systemic anticoagulation",
                    "criterion": "systemic anticoagulation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}